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Completed

NCT Number: NCT02755831

Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.

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Key information

About this study

Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
  • Between 6 and 16 weeks gestation at time of enrollment.

Exclusion criteria

  • Current diagnosis and treatment of OSA.
  • Patient refusal to randomization.
  • Permanent Pacemaker (interfere with WATCHPAT sleep study).
  • Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
  • Coronary artery disease or congestive heart failure or cardiomyopathy.
  • Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
  • Inability to read or understand the consent.
  • <18 years of age.

Treatment and study plan

CPAP

Device

Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea

Pre-natal care

Other

Standard Pre-Natal Care

Primary outcomes

  1. Number of Participants With Adverse Pregnancy Outcomes

    Time frame: time of delivery

    Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)

Secondary outcomes

  1. Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)

    Time frame: early pregnancy (6-16 weeks)

    Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.

  2. Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)

    Time frame: 27-33 weeks

    Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point

  3. Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group

    Time frame: 8-12 weeks postpartum

    Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.

  4. Hospital Costs at Time of Delivery

    Time frame: Hospital costs at time of delivery

    Hospital costs at time of delivery in treatment and control group.

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Registry information

Official study title

Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2016
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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